Device Classification Name |
intervertebral fusion device with integrated fixation, lumbar
|
510(k) Number |
K141791 |
Device Name |
BIOMET FUSION SYSTEM |
Applicant |
BIOMET SPINE |
310 INTERLOCKEN PARKWAY |
BROOMFIELD,
CO
80021
|
|
Applicant Contact |
TED KUHN |
Correspondent |
BIOMET SPINE |
310 INTERLOCKEN PARKWAY |
BROOMFIELD,
CO
80021
|
|
Correspondent Contact |
TED KUHN |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/02/2014 |
Decision Date | 10/09/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|